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Frozen ShoulderMENO-FROSTNCT07603089

Exploring the Link Between Menopause, Glucose Control, and Frozen Shoulder in Women

An observational study of Frozen Shoulder, run by University of Nottingham.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Background Frozen shoulder (FS) is a common condition and affects how the shoulder moves, making it very stiff and sore. The shoulder joint becomes inflamed and tightened due to scarring in the joint called fibrosis. It can take years to get better, and for around 50% of individuals the symptoms last even longer. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Frozen Shoulder
How many people
340 participants
Where
No sites listed yet
Study dates
Aug 2026to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Part 1: Any woman over 18 years of age with a current or previous history of frozen shoulder Part 2: Perimenopausal women with recent diagnosis of primary frozen shoulder and matched controls

Who may be able to join

  • Any women > 18 years with a history of frozen shoulder diagnosed by a clinician
  • Perimenopausal women (self-assessment)
  • Aged 40-60 years
  • Diagnosed with FS within the last 12 months OR
  • Matched controls (women aged 40-60 years without FS).

Who cannot join

  • Any women without a clear previous diagnosis of frozen shoulder
  • Part 2:
  • Diabetes mellitus,
  • Thyroid dysfunction,
  • Secondary FS (e.g. posttraumatic),
  • Use of medications influencing hormonal or metabolic parameters (e.g. hormone replacement therapy [HRT].

About this study

Official title: Exploring the Association Between Menopausal Status, Metabolic Health, and Frozen Shoulder in Women: a Cross-sectional Observational Study

Background

Frozen shoulder (FS) is a common condition and affects how the shoulder moves, making it very stiff and sore. The shoulder joint becomes inflamed and tightened due to scarring in the joint called fibrosis. It can take years to get better, and for around 50% of individuals the symptoms last even longer. FS causes a profound negative impact on physical and mental health, including disturbed sleep, low mood, difficulty performing everyday activities and, in many cases, are unable to continue working. FS affects around 1 in 10 people, and almost twice as many women as men between the ages of 40-60 years, but it is unknown why. It is thought to either be related to changes in sex hormones during the menopause, or due to the way the body handles sugar and fat, which changes with the menopause. However, associations between the menopause transition and FS are not well established and previous evidence has been poor quality. Current treatments include physiotherapy, a steroid injection or surgery but none of these treat the underlying cause of FS. Women with FS said they would like to know why they developed FS and more early treatment options to avoid a long recovery or an operation.

Read more

Aim This study aims to understand if there is a link between the menopause, changes in blood sugar levels and FS in women.

Plan In Part 1, women who have had FS will fill in an electronic questionnaire to give us information about their menopause status at the onset of FS, how long their symptoms lasted, what treatments they tried, and if they had any other health conditions. This will enable us to determine the relationship between the menopause and the onset of FS.

In Part 2, the investigators will invite 18 perimenopausal women with recently diagnosed FS and 18 matched women without FS to attend a one-day visit at the University of Nottingham. The investigators will measure their blood sugar levels over two weeks using a small monitor on their arm. The investigators will assess their menopause symptoms and shoulder related outcomes using validated questionnaires. The investigators will assess their shoulder movement and measure body fat and muscle levels, physical activity levels, diet, and take a blood sample to test sex hormones, inflammation and lipids, as well as markers related to frozen shoulder. This will help us to assess the relationship between blood glucose control and the onset of FS in perimenopausal women.

Impact This research will help us understand if there's a link between menopause, blood sugar control, and FS. It could lead to new clinical trials testing treatments early in FS, such as a glucose lowering medication or hormone therapy, to help women recover faster and avoid surgery. This may improve clinical outcomes in women with FS and reduce costs associated with treating FS. This important question came directly from patients and has not been studied in depth before. The investigators plan to share the results widely through health newsletters, podcasts, research conferences, and medical journals.

Conditions
Frozen Shoulder
Keywords
frozen shoulder, menopause, glucose
Medical subject headings
Bursitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Menopause status at frozen shoulder onset

    Part 1: • Self-reported menopause status at the time of FS onset

    Measured: Baseline

  2. Estimated HbA1c

    Part 2: Estimated HbA1c from continuous glucose monitoring (CGM)

    Measured: 14 days

Secondary outcomes (5)
  1. Type of menopause

    Part 1: Type of menopause

    Measured: Baseline

  2. Frozen shoulder duration

    Part 1: Duration of FS symptoms

    Measured: Baseline

  3. BMI and waist circumference

    Part 2: weight and height will be combined to report BMI in kg/m^2

    Measured: Baseline

  4. Serum fasting lipids

    Part 2: serum fasting lipid concentration

    Measured: Baseline

  5. Step count

    Part 2: activity data from ActivPAL

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603089
Sponsor's protocol ID
26018
Acronym
MENO-FROST
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Frozen Shoulder, run by University of Nottingham.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menopause status at frozen shoulder onset (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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